Poster Presentation at the 2011 ARVO Conference Reviews NovaBay's Expanding
Portfolio of Aganocide Compounds Exhibiting Significant Activity against Viral,
Bacterial and Fungal Ocular Pathogens
EMERYVILLE, Calif., May 6, 2011 (GLOBE NEWSWIRE) -- NovaBay® Pharmaceuticals, Inc. (NYSE Amex:NBY) presented a poster at the 2011 Conference of the Association for Research in Vision and Ophthalmology (ARVO) held this week in Fort Lauderdale, Florida. The poster was prepared by researchers from NovaBay Pharmaceuticals and Kathryn Najafi, MD, Ophthalmologist of Eye Institute of Marin in San Rafael, California and titled "Aganocide® Compounds Effective Against Ophthalmic Pathogens."
Similar to NovaBay's lead anti-infective Aganocide compound, NVC-422, these new compounds, NVC-727, NVC-638, and NVC-704 are broad-spectrum, fast-acting antimicrobial agents with the same mechanism of action. However, they possess unique differentiating activity profiles. In this poster, NVC-727 was effective against adenovirus and HSV-1 with a good activity against S. aureus, and E. coli. NVC-727 showed fast time-kill in 10% synthetic tears and human donor tears at pH 7 against S. aureus and HSV-1. NVC-638 and NVC-704 are novel structural series with good antibacterial and antiviral ( HAdV-5) and (HSV-1) activity at pH 4.
Mark Anderson, PhD, NovaBay's Chief Scientific Officer, stated, "NVC-727, NVC-638, and NVC-704 are very exciting new molecules in our growing portfolio of broad-spectrum, fast-acting, Aganocide compounds. These compounds also provide an opportunity to treat other unmet medical needs in dermatology, urology and wound care without development of resistance. In ophthalmology, we are uniquely positioned to develop an eye drop that will treat both bacterial and viral causes of conjunctivitis including Epidemic Keratoconjunctivitis also known as EKC."
Multiple ocular pathogens are responsible for conjunctivitis (pink eye). These include bacterial infections caused by Staphylococcus aureus and Haemophilus influenza and viral infections caused by the herpes simplex virus-1 (HSV-1), and human adenoviruses (HAdV). Some HAdV serotypes result in inflammation of the conjunctiva (the thin, transparent tissue that covers the outer surface of the eye). Epidemic keratoconjunctivitis (EKC) is a severe and highly contagious eye infection which can lead to severe visual impairment. EKC induces inflammation of both the cornea and the conjunctiva resulting in mild to severe cases of blurred vision and subepithelial infiltrates (white lesions on the corneal surface). The inflammation on the cornea and subepithelial infiltrates can reduce the patient's vision and often cause photophobia (light sensitivity) for weeks to months post-infection. Patients presenting with viral or bacterial conjunctivitis are often difficult to quickly differentiate by eye care professionals thereby requiring additional tests to identify the causative pathogen. Furthermore, there are no therapies approved for adenoviral conjunctivitis by the US FDA or anywhere else in the world.
About Adenoviral Conjunctivitis ("Pink Eye")
Adenoviral conjunctivitis, a highly contagious ocular infection, is an unmet medical need. Conjunctivitis is an inflammation of the conjunctiva, a thin, transparent layer covering the surface of the inner eyelid and the front of the eye. It affects people of all ages. Acute conjunctivitis from various etiologies is characterized by common symptoms and signs including a red eye, discharge, eyelash matting or crusting, foreign body sensation, and tearing. Adenovirus is a very robust virus that can survive outside the body on hard surfaces and has been cultured from such surfaces up to 7 weeks after an infection. Patients affected by EKC are often advised by physician not to attend work or school any where from 1-2 weeks leading to loss of work time and absenteeism. Approximately 45% of people in a patient's close surroundings, e.g., family members, will become infected. Approximately 3 million school days are lost annually as a result of acute conjunctivitis. Although exact numbers are difficult to determine, estimates suggest the number of cases of ocular adenoviral infections may be as high as 15-20 million per year in the United States.
Epidemic keratoconjunctivitis (EKC) is a serious and contagious eye infection affecting both the conjunctiva and more problematically, the cornea (the transparent front part of the eye that covers the iris, pupil, and anterior chamber). EKC infections are caused by adenoviruses type: 8, 19 and 37. EKC is characterized by conjunctivitis: acute onset of watering, redness, foreign body sensation and severe pain. Symptoms include blurred vision, light sensitivity and foreign body sensation. In aggressive cases of EKC, corneal scarring due to subepithelial infiltrate (SEI's) and conjunctival scarring due to membrane or pseudo membrane can be seen. During the acute phase, which persists for approximately two-three weeks, viruses are present and replicating. In the typical case, first one eye is infected, after which the infection spreads to the other eye within two to three days. Both eyes are affected in 60% of cases. The infection in the first eye is typically the more serious. In approximately 20 - 50% of patients, corneal opacities are developed due to SEI's resulting in deteriorating vision that remain for weeks and months, and in rare cases even years. Since the disease is often epidemic in nature, it is called epidemic keratoconjunctivitis (EKC).
About NovaBay's Aganocide Compounds
NovaBay's Aganocide compounds are novel, broad-spectrum, fast-acting, synthetic N-chlorinated antimicrobial molecules designed to mimic the body's defense against infection. When applied to the site of an infection, these compounds maintain biological activities while demonstrating improved solution stability over naturally occurring N-chlorinated antimicrobial molecules. In July 2010, NovaBay announced positive results in a 129-patient, Phase 2a impetigo skin infection study. The results showed 92% of the patients in NovaBay's highest dose were cured of the highly contagious infection following seven days of treatment with NovaBay's lead Aganocide compound (NVC-422) topical gel. Patients in the study infected with methicillin-resistant Staphylococcus aureus (MRSA) impetigo infection were successfully treated. Additionally, Aganocide compounds have shown good in-vitro activity against viruses and fungi and have the potential to deliver the same or better efficacy than antibiotics, and to address the growing problem of antibiotic resistance by employing a novel mechanism of action.
About NovaBay Pharmaceuticals, Inc.
NovaBay Pharmaceuticals is a clinical-stage biotechnology company focused on developing its proprietary and patented Aganocide compounds. These are novel, synthetic anti-infectives with activity against bacteria, fungi and viruses, and are being developed to treat and prevent a wide range of local, non-systemic infections with a low likelihood of developing bacterial resistance.
NovaBay is focusing its technology on four distinct therapeutic areas: dermatology, ophthalmology, urology and hospital infections. In dermatology, the focus is on developing NVC-422 gel for impetigo and acne. NovaBay has the advantage of being partnered with Galderma, the leading dermatology company in the world. In ophthalmology, the goal is to develop an eye drop for conjunctivitis with Alcon, the world's foremost ophthalmology company. In urology, NovaBay aims to reduce the incidence of urinary catheter blockage and encrustation (UCBE) and the associated urinary tract infections with an irrigation solution containing NVC-422. In hospital infection, NovaBay is targeting the six-million-patient market of chronic non-healing wounds, such as pressure, venous stasis and diabetic ulcers with its proprietary antimicrobial solution, NeutroPhase®, which has received two 510(k) clearances from the Food and Drug Administration. For additional information, visit www.novabaypharma.com.
Cautionary Information Regarding Forward-Looking Statements
The statements in this press release regarding NovaBay's expectation on the potential efficacy of Aganocide compounds particularly NVC-422, NVC 638, NVC 704 and NVC 727; the potential to develop an eye drop that will treat both bacterial and viral conjunctivitis including EKC, as well as other statements that relate to future events or results are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward- looking statements reflect the views of the management of NovaBay as of the date of this press release and are based on assumptions and subject to significant risks and uncertainties (many of which are outside of NovaBay's control), including, but are not limited to:; the risk that results obtained in preclinical studies may not be obtained in humans; NovaBay's Aganocide compounds may not prove to be effective in treating viral and bacterial conjunctivitis; and the FDA or other regulatory agencies may delay clinical trials, or require additional studies or procedures, which could delay or prevent the development of Aganocide compounds. These and other risks relating to the development of Aganocide compounds are detailed in NovaBay's filings with the Securities and Exchange Commission, including in the section entitled "Risk Factors" in Item 1A of Part 1 of NovaBay's Annual Report on Form 10-K for the period ended December 31, 2010, filed with the Securities and Exchange Commission on March 10, 2011. The forward-looking statements in this release speak only as of this date, and NovaBay disclaims any intent or obligation to revise or update publicly any forward-looking statement except as required by law.